Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Type 2 Diabetics

Adistem

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Procedure: Autologous Adipose-derived Stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT00703612

Adis-002

Details and patient eligibility

About

The purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics.

Full description

Diabetes Mellitus is of large epidemic proportions worldwide. It is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. The purpose of this Phase 1/Phase 2 study is to determine whether the intavenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe to and can benefit the disease pathology of patients with Type 2 Diabetes Mellitus (insulin resistance). Patients will be observed over 12 months following the procedure, with a 2 week, 1 month and then tri monthly diagnostics and life style questionaires.

Enrollment: 34 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of Type II diabetes for at least 2 years
• Type 2 diabetics on oral hypoglycemic agents and/or insulin
• Fasting blood sugar of >200mg% on at least two occasions
• Willing to keep a weekly diary and undergo observation for 12 months

Exclusion criteria

• Presence of of previous and/or acute diabetic complications such as myocardial infarction, CVA or nephropathy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

34 participants in 1 patient group

Treatment Group

Experimental group

Description:

This is the only arm and that is the treatment group.

Treatment:

Procedure: Autologous Adipose-derived Stem cells